FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal ...
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...
Lupus Foundation of America1d
FDA Accepts Supplemental Biologics License Application for Gayzva for Treatment of Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for ...
PharmExec1d
FDA Accepts Roche’s Supplemental Biologics License Application for Gazyva/Gazyvaro in Lupus Nephritis
Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients ...
PharmExec3d
FDA Accepts Biologics License Application for GSK’s Depemokimab for Asthma with Type 2 Inflammation and CRSwNP
In the SWIFT and ANCHOR trials, depemokimab demonstrated statistically significant reductions in nasal polyp size, ...
Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration
We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential ...
F. Hoffmann-La Roche Ltd: FDA accepts supplemental Biologics License Application for Roche's Gazyva/Gazyvaro for the treatment of lupus nephritis
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit1 The filing application is based on data from the phase ...
Genentech gets FDA acceptance for its Lupus treatment's license application
Genentech, a Roche Group company(OTCQX:RHHBY) said on Wednesday that the U.S. FDA accepted the company’s supplemental ...
Medical Dialogues2d
USFDA accepts GSK depemokimab applications for review for asthma, chronic rhinosinusitis
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License ...
Medical Dialogues1d
Roche Gazyva application accepted by USFDA for lupus nephritis
Gazyva/Gazyvaro is an anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a CRR benefit in lupus ...
Investing.com UK3d
US FDA accepts GSK’s application for Depemokimab review
Investing.com -- The US Food and Drug Administration has accepted GlaxoSmithKline (NYSE: GSK )’s biologics license ...
FDA Accepts Depemokimab Applications For Asthma With Type 2 Inflammation And CRSwNP
GSK plc (GSK) has announced on Monday that the FDA has accepted its Biologics License Application (BLA) for depemokimab for regulatory review in two indications.The proposed ...